The FINANCIAL — AstraZeneca on April 14 announced that the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13 to 1 (1 abstained; 15 total votes) that the results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) study demonstrated that the use of saxagliptin in patients with type 2 diabetes has an acceptable cardiovascular risk profile.
In addition, 14 out of 15 Committee members recommended that the FDA supplement the products’ labeling to add new safety information, with one vote to withdraw saxagliptin from the market, according to AstraZeneca.
AstraZeneca will also conduct further investigation to better understand the signal of hospitalisation for heart failure found in the SAVOR results.
The Advisory Committee was asked to consider data from SAVOR, a large, randomised, double-blind, placebo-controlled postmarketing study designed to evaluate the cardiovascular effects of ONGLYZA when added to current type 2 diabetes background therapy in adult patients with type 2 diabetes mellitus at risk for cardiovascular disease.
SAVOR met the primary safety objective, demonstrating that ONGLYZA did not increase the risk for cardiovascular death, nonfatal myocardial infarction and nonfatal ischemic stroke when added to a patient’s current standard of care, with or without other antidiabetic therapies, as compared to placebo. The supplemental New Drug Applications (sNDAs) based on the SAVOR results, if approved, will provide prescribers and patients important additional information about the benefit-risk profile of ONGLYZA and KOMBIGLYZE XR.
The Advisory Committee was convened to discuss previously submitted sNDAs to the FDA for ONGLYZA and KOMBIGLYZE XR. The FDA is not bound by the Advisory Committee’s recommendation but takes its advice into consideration when reviewing these sNDAs. AstraZeneca remains committed to working closely with the FDA to support further review of these sNDAs.
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